Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors

Pharma Mar

Status and phase: Completed; Phase 2

Conditions: Solid Tumors

Treatments: Drug: lurbinectedin (PM01183)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02451007

PM1183-B-005-14-QT

Details and patient eligibility

About

Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected solid tumors.

Enrollment: 39 patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntarily signed and dated informed consent
• Normal cardiac conduction and function (centrally read)
• Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic.
• Specific serum electrolyte levels

Exclusion criteria

• Age > 65 years
• Performance status = 2 [Eastern Cooperative Oncology Group (ECOG)]
• Heart rhythm disturbances
• Significant ischemic coronary disease, heart failure, myocardial infarction, or unstable angina within the last six months.
• Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) > 450 mg/m²

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

A (lurbinectedin)

Experimental group

Description:

lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion

Treatment:

Drug: lurbinectedin (PM01183)